Needle, Hypodermic, Single Lumen

FDA product code FMI · 670 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5570
Review panel: HO
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-16 – 2026-09-17

FMI 1985-10-18

HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX

Applicant Gish Biomedical, Inc.

K number K853731

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FMI 1985-09-20

PHARMA-PLAST NEEDLE

Applicant Pharma-Plast USA, Inc.

K number K852442

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FMI 1985-09-19

NON-KOR ACCESS KITS

Applicant Creative Care Systems, Inc.

K number K852831

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FMI 1985-07-16

VASCULAR IMPLANT ACCESS NEEDLE SET

Applicant Baxter Healthcare Corp

K number K851103

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FMI 1985-04-29

JMS NEEDLES & JMS SYRINGES

Applicant Jms Co., Ltd.

K number K845043

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FMI 1985-04-24

CHURCHILL HABER POINT NEEDLE ADMIN. SET

Applicant Churchill Corp.

K number K850420

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FMI 1985-01-22

INFUSET W/HUBER NEEDLE

Applicant Med Fusion Systems, Inc.

K number K844313

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FMI 1984-12-17

MONOJECT MENGHINI SOFT TISSUE BIOPSY

Applicant Sherwood Medical Co.

K number K843264

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FMI 1984-11-30

GAINOR MEDICAL FLOWMAX NEEDLES

Applicant Gainor Medical

K number K844305

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FMI 1984-08-20

AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY

Applicant American Pharmaseal Div. Ahsc

K number K842542

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FMI 1984-07-23

BUTTERFLY II PN INFUSION NEEDLE

Applicant Cosmetic Sciences, Inc.

K number K842756

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FMI 1984-07-17

HESUNG'S HYPERDERMIC NEEDLES

Applicant Amkor Trading Co.

K number K841565

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FMI 1984-07-06

UMI CURVED CHEMONUCLEOLYSIS NEEDLE

Applicant Universal Medical Instrument Corp.

K number K842012

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FMI 1984-07-06

NON-CORING NEEDLE

Applicant Creative Care Systems, Inc.

K number K841742

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FMI 1984-06-28

THINWALL PUNCTURE NEEDLE

Applicant Meadox Surgimed, Inc.

K number K841704

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FMI 1984-06-04

HEPARIN LOCK FLUSH SOLUTION USP KIT,100

Applicant Solo Pak Laboratories

K number K841306

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FMI 1984-06-04

HEPARIN LOCK FLUSH SOLUTION USP KIT

Applicant Solo Pak Laboratories

K number K841305

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FMI 1984-06-04

HEPARIN LOCK FLUSH PROCEDURE PACK

Applicant Solo Pak Laboratories

K number K841166

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FMI 1984-05-09

BETAJECT BD U100

Applicant Orange Medical Instruments, Inc.

K number K833705

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FMI 1984-05-07

HYPODERMIC NEEDLES

Applicant Ava Medical Products of Canada, Inc.

K number K841577

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FMI 1984-04-27

PICKER MYELOGRAM TRAY-PMS MYELOGRAM

Applicant Professional Medical Systems

K number K841217

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FMI 1984-04-13

INFUSION NEEDLE IIPN

Applicant Medi Tex, Inc.

K number K840944

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FMI 1984-04-13

CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY

Applicant Applied Medical Devices, Inc.

K number K840334

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FMI 1984-04-05

HYPODERMIC NEEDLES & STYLETS

Applicant Microvasive

K number K840033

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FMI 1984-03-30

INTRAVENOUS NEEDLE

Applicant Yolan R. Guttman

K number K832904

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FMI 1984-03-23

OHIO HEAT REFLECTING PATCH

Applicant Ohio Medical Products

K number K840967

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FMI 1984-03-19

STERILE DISPOSABLE SPINAL NEEDLES

Applicant Hydro-Med Products, Inc.

K number K834407

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FMI 1984-03-15

CHEMONUCLEOLYSIS NEEDLE

Applicant Universal Medical Instrument Corp.

K number K834436

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FMI 1984-03-06

INTRADISCAL THERAPY TRAY

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K834553

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FMI 1983-10-27

GUTTMAN INFUSION NEEDLE

Applicant Cosmetic Sciences, Inc.

K number K830568

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FMI 1983-09-29

INTRADISCAL THERAPY TRAY

Applicant Ulti-Med Intl., Inc.

K number K832858

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FMI 1983-09-12

NEONATAL LUMBAR PUNCTURE TRAY

Applicant American Pharmaseal Div. Ahsc

K number K832556

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FMI 1983-09-01

STERILE DISPOSABLE NEEDLES

Applicant Lee Medical Intl., Inc.

K number K832102

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FMI 1983-08-24

BUTTON INFUSER

Applicant Markwell Medical Institute, Inc.

K number K831063

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FMI 1983-07-26

AVL 0073 MICROSAMPLER

Applicant Avl Scientific Corp.

K number K831395

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FMI 1983-07-12

HERAPIN LOCK FLUSH SOLUTION USE KIT

Applicant Smith & Nephew, Mpl Division

K number K831765

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FMI 1983-07-12

INTRADISCAL THERAPY NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K831610

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FMI 1983-04-14

INFANT CARE SYSTEM

Applicant Narco Scientific

K number K823899

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FMI 1983-02-15

MICRO 2 HYPODERMIC NEEDLES

Applicant Smith & Nephew, Mpl Division

K number K830242

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FMI 1983-02-07

MYELOGRAPHY NEEDLE

Applicant Ocean Medical Products, Ltd.

K number K823693

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FMI 1983-01-26

MICRO Z BLOOD COLLECTING NEEDLES

Applicant Hospital Products Co.

K number K823696

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FMI 1982-11-22

NON-STERILE REUSABLE NEEDLES

Applicant Vertex Medical Corp.

K number K823255

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FMI 1982-06-09

DISPOSABLE HYPODERMIC NEEDLES

Applicant Medcare Disp Products, Inc.

K number K821529

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FMI 1982-04-15

PBC NEEDLE BY NIPRO MED. INDUSTRIES

Applicant Philadelphia Biologics Center

K number K820911

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FMI 1982-03-25

HYPODERMIC & SUTURE NEEDLES

Applicant Needle Industries(Usa), Inc.

K number K813256

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FMI 1982-01-28

PBC NEEDLE

Applicant Philadelphia Biologics Center

K number K813649

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FMI 1982-01-28

JMS NEEDLE & MAC JECT

Applicant Philadelphia Biologics Center

K number K813648

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FMI 1982-01-12

HYPOSERMIC NEEDLES

Applicant Optical Micro Systems, Inc.

K number K813545

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FMI 1981-11-06

MEDISYSTEMS NEEDLES & SYRINGES

Applicant Medisystems Corp.

K number K812910

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FMI 1981-09-09

BUTTERFLY NEEDLE ASSEMBLY

Applicant Nu Tech Medical Systems

K number K812404

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FMI 1981-07-23

VISITEC NEEDLE RANGE (GENERAL HOSPITAL)

Applicant Visitec Co.

K number K811966

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FMI 1980-09-16

DISPOSABLE HYPODERMIC NEEDLES

Applicant Martin'S Maine Exchange

K number K801839

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FMI 1980-08-12

PAN-AM MYELOGRAM TRAY

Applicant Waters Assoc., Inc.

K number K801431

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FMI 1980-05-30

DOUBLE ENDED VENTED TRANSFER DEVICE

Applicant Burron Medical Products, Inc.

K number K801108

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FMI 1980-05-30

DOUBLE ENDED FILTERED TRANSFER NEEDLE

Applicant Burron Medical Products, Inc.

K number K801107

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FMI 1979-11-16

2 FR KELMAN CHAMBER MAINTAINER

Applicant Heyer Schulte Corp.

K number K792096

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FMI 1979-09-24

HYPERDERMIC NEEDLE WITH SENSOR #514

Applicant Medtech Intl., Inc.

K number K791462

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FMI 1979-07-30

AMIPAQUE MYELOGRAM TRAY

Applicant Pharmaseal Div., Baxter Healthcare Corp.

K number K791156

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FMI 1979-06-27

BORDISPO BRAND HYPODERMIC NEEDLE

Applicant Borda Products, Inc.

K number K790953

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FMI 1979-02-08

NEEDLE, TRUCARE VACUTAINER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K790086

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FMI 1978-04-10

DILUTION SPIKE

Applicant Sterling Drug, Inc.

K number K780209

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FMI 1977-10-13

BLOOD GAS TRAY #4024

Applicant Concord Laboratories, Inc.

K number K771667

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FMI 1977-07-26

TERUFUSION BLOOD ADMIN. SET

Applicant Terumo America, Inc.

K number K771209

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FMI 1977-07-14

TERUFUSION DONOR SET

Applicant Terumo America, Inc.

K number K771207

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FMI 1977-07-14

DISP. HYPODERMIC NEEDLE

Applicant Terumo America, Inc.

K number K771203

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FMI 1977-04-29

NEEDLE, MEMBRANE

Applicant American Viggo

K number K770528

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FMI 1977-04-15

NEEDLES, STERILE, AIRWAY

Applicant Pfizer Pharmaceuticals

K number K770425

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FMI 1977-03-16

CONVENIENCE TRAY

Applicant Johannah Medical Services, Inc.

K number K770370

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FMI 1977-01-28

FILTER DEVICES

Applicant Arrow Intl., Inc.

K number K761098

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FMI 1976-11-16

DOUBLE-ENDED NEEDLE

Applicant Travenol Laboratories, S.A.

K number K760780

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